[关键词]
[摘要]
目的 考察雷贝拉唑钠肠溶片的溶出度,评价其体外溶出一致性。方法 采用高效液相色谱法测定雷贝拉唑钠肠溶片含量,并进行专属性、回收率、精密度、稳定性等方法学考察,以原研药为参比制剂,采用篮法考察国产雷贝拉唑钠肠溶片在pH 1.2、6.8、8.0三种溶出介质中的溶出度并绘制溶出曲线,其中在pH8.0溶出介质中考察了转速(100、75 r/min)对药物溶出行为的影响,以f2相似因子法比较溶出曲线的相似性。结果 色谱条件为色谱柱:Diamonsil C18(150 mm×4.6 mm,5 μm);流动相:0.015 mol/L磷酸氢二钠溶液(磷酸调节pH值至7.0)-乙腈55:45;体积流量1 mL/min;柱温30℃;检测波长290 nm;进样量20 μL。方法学验证结果均符合检测要求。国产雷贝拉唑钠肠溶片在pH 1.2溶出介质中溶出曲线与参比制剂一致,在pH 6.8溶出介质中仅有1个厂家的溶出曲线与参比制剂相似,在pH 8.0溶出介质中有2个厂家的溶出曲线与参比制剂相似,且不同转速对药物的溶出行为无明显影响,其余厂家溶出曲线与参比制剂均有较大差异,且在3种溶出介质中没有与参比制剂溶出曲线均相似的厂家。结论 国产雷贝拉唑钠肠溶片仿制药与参比制剂的体外溶出行为不一致。
[Key word]
[Abstract]
Objective The dissolution of domestic rabeprazole sodium enteric-coated tablets was investigated and the in vitro dissolution consistency was evaluated. Methods A method for the determination of rabeprazole sodium enteric-coated tablets was established using high performance liquid chromatography. The original drug was used as a reference preparation, and the dissolution of the domestic rabeprazole sodium enteric-coated tablets in three dissolution media of pH 1.2, 6.8 and 8.0 was investigated by the basket method. Then, the dissolution curves were drawn according to the dissolution results, and the similarity of the dissolution curves were compared by f2 similarity factor method. The effect of rotational speed on drug dissolution behavior was also investigated in pH 8.0 dissolution medium. Results The chromatographic conditions were as follows:chromatographic column:diamonsil C18 (150 mm×4.6 mm, 5 μm); mobile phase:0.015 mol/L disodium hydrogen phosphate solution (adjusted to pH 7.0 by phosphoric acid)-acetonitrile 55:45; volume flow rate 1 mL/min; column temperature 30 ° C; detection wavelength 290 nm; injection volume 20 μL. The results of methodology validation met the detection requirements. The dissolution curve of domestic rabeprazole sodium enteric-coated tablets in the dissolution medium at pH 1.2 was consistent with that of the original drug, while the dissolution curve of only one manufacturer in pH 6.8 dissolution medium of was similar to that of the original drug. In pH 8.0 dissolution medium, the dissolution curves of two manufacturers were similar to those of the original drug, and the dissolution behavior was not significantly affected by different rotation speeds. The dissolution curves of the other manufacturers are significantly different from the original drug, and no manufacturer has similar dissolution curves with the original drug in the three media. Conclusion The dissolution behavior of domestic rabeprazole sodium enteric-coated tablets is inconsistent with that of the original drug.
[中图分类号]
R927.11
[基金项目]
北京医卫健康公益基金资助项目(YWJKJJHKYJJ-A825)